The Effectiveness of a Novel Lip Product Containing Caulerpa Lentillifera Extract for Reducing Lip Hyperpigmentation

Not Applicable

Recruiting

• Conditions: Hyperpigmentation

• Registration Number: NCT07067879
• Lead Sponsor: Chulalongkorn University

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of the novel lip product containing Caulerpa lentillifera extract on the appearance and perception of dark lips in Thai adults aged 18 to 60 who report concerns about darkened lips. The main question it aims to answer is: Can the novel lip product containing C. lentillifera extract will significantly improve the appearance and perception of dark lips in Thai adults by reducing hyperpigmentation compared to baseline measurements?

Participants will apply the lip product twice a day, in the morning after breakfast and before bedtime, and refrain from using other lip products throughout the clinical trial period (7 days).

Researchers will compare the result to baseline measurements

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Study Start: 2025-07-23
• Primary Completion: 2025-08-13
• Study Completion: 2025-08-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Understand the study protocol and provide informed consent after being informed of potential risks and benefits.
• Refrain from using any other lip products, including lipstick, lip gloss, or lip conditioners, during the study period.

Exclusion Criteria

• Have a known allergy or sensitivity to cosmetic products or Caulerpa lentillifera.
• Are on medication one month prior to study commencement.
• Exhibit lip abnormalities such as malformation, inflammation, swelling, or sores.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in improving lip hyperpigmentation	Baseline and 7 days	Lip hyperpigmentation is assessed using Antera3D at baseline and 7 day after usage

Secondary Outcome Measures

Name	Time	Method
Change from baseline in improving lip dryness	Baseline and 7 days	Lip dryness is assessed using Fotofinder system at baseline and 7 day after usage
Subjective assessment by participants	Baseline, day 1, and day 7	Participants' evaluations will be collected through an online self-reported questionnaire. Subjective perceptions of lip color and dryness will be assessed using a 0-10 numerical darkness and dryness scale. Additionally, a satisfaction rating questionnaire will be administered to assess participant satisfaction with their lip appearance and the lip product on day 1 and day 7. The questionnaire will evaluate six key aspects of product performance; 1. Overall satisfaction; 2. Effectiveness in hydration and moisturization; 3. Improvement in lip color and texture; 4. Ease of use and packaging design; 5. Sensory attributes such as texture and scent; 6. Occurrence of any adverse reactions

Trial Locations

Locations (1)

Faculty of dentistry, Chulalongkorn university; 🇹🇭 Bangkok, Thailand